Population-based Research to Optimize the Screening Process
(PROSPR) is the National Cancer Institute (NCI) program to promote research
aimed at evaluating and improving the cancer screening process. As a part of
the reissued PROSPR program, this Funding Opportunity Announcement (FOA)
solicits applications for a PROSPR U24 Coordinating Center. A companion FOA (RFA-CA-16-016)
will support PROSPR UM1 Research Centers.

The overall goal for the PROSPR Research Centers is to
enhance understanding of the implementation and effects of screening as
practiced in multiple healthcare environments in the United States.

The intent of this FOA is to fund a single Coordinating
Center that will support a network of three PROSPR Research Centers (PRCs;
one each focused on cervical, colorectal, and lung cancer). Specifically, the
Coordinating Center will facilitate the development of common measures across
cancer types for (1) system-level factors that may impact the cancer
screening process, and (2) quality of screening. It will also coordinate
PROSPR network research projects that include more than one cancer type.
Finally, the Coordinating Center will be responsible for developing and
implementing a process for PROSPR data access and sharing with qualified
investigators outside of the PROSPR network.

Key Dates

Posted Date

October 24, 2016

Open Date (Earliest Submission Date)

January 9, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

February 9, 2017, by 5:00 PM local time of applicant
organization. All applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for the Funding
Opportunity

Announcement.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2017

Advisory Council Review

October 2017

Earliest Start Date

December 2017

Expiration Date

February 10, 2017

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the instructions in
the Research Instructions for the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

Population-based Research to Optimize the Screening Process
(PROSPR) is the National Cancer Institute (NCI) program to promote research
aimed at evaluating and improving the cancer screening process. The reissued
PROSPR program comprises two Funding Opportunity Announcements (FOAs) that
solicit applications for:

PROSPR U24 Coordinating Center (PCC) (this
FOA); and

PROSPR
UM1 Research Centers (PRCs) (a companion FOA, RFA-CA-16-016).

The overall goal for the PROSPR Research Centers is to
enhance understanding of the implementation and effects of screening as
practiced in multiple healthcare environments in the United States.

The purpose of this Funding Opportunity Announcement (FOA)
is to support a Coordinating Center that will provide scientific guidance and support
in certain areas to three PROSPR Research Centers (one each focused on
cervical, colorectal, and lung cancer, covered by RFA-CA-16-016).
The Coordinating Center will serve as an intellectual hub for network research
that is focused on more than one cancer type, with specific emphasis on
development of two sets of common measures: health system-level characteristics
that impact the cancer screening process and indicators of screening quality.
It will also develop processes for proposing and conducting research that
includes two or more PROSPR Research Centers (RFA-CA-16-016),
and oversee data analysis and timely completion of these projects. Finally, it
will develop and implement a process for PROSPR data access by qualified
outside investigators.

Key Definitions for the context of this
FOA:

Healthcare
system: a collection of primary and specialty care clinicians
and support staff, medical facilities, and organizational structures which
together provide the environment for the comprehensive delivery of healthcare
services related to the cancer screening process, from determination of
screening eligibility through treatment of benign precursor or malignant
disease diagnosed through screening.

Community
settings: Environments in which the process of delivering
healthcare reflects approaches typically followed by clinicians whose primary
responsibilities are patient care rather than research or education. Patients
in these environments tend to be more representative of the local population
than are patients referred to academic medical centers for specialty care or
who are enrolled in clinical trials.

Background

Cancer Screening as a Complex Process. Cancer
screening is not a single test, but a complex process that involves multiple
steps: (1) determination of patient eligibility for screening and invitation for
screening, (2) performance of the screening test and interpretation of results,
(3) diagnostic follow-up of those with abnormal screening examinations, and (4)
referral for treatment of benign precursor lesions and/or malignant cancers
that are diagnosed. And, in fact, each of these steps can be broken down to
identify sub-steps which healthcare staff and patients must complete. Successful
completion of each of these steps is necessary for maximal screening benefits
to be achieved. Conversely, breakdowns at any point in the process can lead to
suboptimal outcomes. Furthermore, screening occurs within healthcare systems
that encompass organizations, medical teams, administrators, and patients, all
of which interact in complex ways to impact the utilization and quality of
medical services provided. Screening process breakdowns thus depend on
multilevel factors including, for example, patient non-compliance, failures on
the part of medical providers or healthcare systems to provide appropriate
follow-up testing and treatment, or failures of the screening or diagnostic
tests themselves to detect disease.

Additionally, both the conduct of high-quality screening and
the measurement of screening quality are difficult. In 2001, the Institute of
Medicine proposed six domains of healthcare quality, stating that healthcare
systems should aim to provide care that is: safe, effective, patient-centered,
timely, efficient, and equitable. However, common conceptualizations and
metrics for measurement of these quality domains across cancer types are
lacking. Lack of these measures of quality impedes the iterative improvement of
cancer screening across the US.

PROSPR I: Accomplishments and Research Gaps.Population-based Research
Optimizing Screening through Personalized Regimens I (PROSPR I) was established
in 2011 to measure the process of cancer screening for breast, colorectal, and
cervical cancer in community settings. PROSPR I established an infrastructure
to evaluate the screening process and to pool data across research centers to
create standard metrics of population-based progress through the screening
process (percent of eligible population screened, percent of individuals with
abnormal results, percent of those with abnormal results who receive
appropriate diagnostic testing, percent of individuals with cancer or benign
precursor lesions who are appropriately treated). The PROSPR I investigators
established the feasibility of documenting these process metrics, characterized
heterogeneity in screening performance across systems, and documented
disparities between populations treated in different healthcare systems.
Despite the progress in PROSPR I, persistent questions remain about what
factors drive the observed heterogeneity between healthcare systems in the
screening process, how those variations affect the quality of care, health
disparities in access to high-quality screening, and the long-term consequences
of screening.

New Opportunities.Several developments
since the funding of PROSPR I provide new opportunities for research to improve
the cancer screening process. First, there have been several changes in the
healthcare environment that have impacted cancer screening. A report by the
National Academy of Medicine described cancer care in the US healthcare system
as "in crisis", and congress passed legislation to increase access to
care. Therefore, new concerns have arisen about how to measure quality, how the
changing of incentive structures affects the screening process, and how
variation in quality is affecting outcomes. Second, in 2011 the United States
Preventive Services Task force for the first time recommended routine lung
cancer screening in high-risk populations, generating questions regarding how
to best implement screening. Third, increasing recognition of the interplay
among characteristics of patient, provider, and healthcare delivery setting
have focused attention on the need for measures of characteristics of the
organizations. Finally, important questions remain regarding long-term effects
of screening and factors that affect breakdowns in the screening process as
they occur over multiple rounds of screening/surveillance. These questions
require additional years of longitudinal data collection to allow for the
accrual of larger numbers of cancer outcomes.

The reissuance of PROSPR is structured to make progress
toward addressing these significant questions.

PROSPR II Objectives and Scope of the FOA

This initiative is being reissued under the modified name of
Population-based Research to Optimize the Screening Process II (PROSPR II). The
overall goal of PROSPR II is to increase our understanding of healthcare system,
provider, and individual level factors that affect the quality of cancer
screening in the United States, in order to improve the cancer screening
process. An important focus of the reissuance is how these factors affect
variation in populations with diverse racial/ethnic, socioeconomic, and healthcare
access characteristics. To that end, a companion FOA (RFA-CA-16-016)
is soliciting applications for PROSPR Research Centers (PRCs) focused on one of
the following cancers: cervical, colorectal, or lung. The NCI intends to fund
one PRC for each cancer type.

The Coordinating Center will provide scientific guidance and
support to the 3 PRCs, and will have 3 major roles:

1. Leading the development of common conceptualizations and
measures for 2 aspects of monitoring the screening process: assessing the role
of systems-level factors that impact the screening process, and assessing screening
quality;

3. Developing and implementing a process to support sharing
of PROSPR data with qualified investigators who are not part of the PRCs, PCC,
or NCI's PROSPR II scientific team.

The Coordinating Center will need to establish collaborative
relationships with each of the PRCs, in order to understand the data
capabilities and research program of each center. With this knowledge the
Coordinating Center, in collaboration with the PRCs, will identify
commonalities in the centers' approaches to evaluating system-level factors and
screening quality, and facilitate the development of common conceptualizations
and metrics to evaluate these factors. These metrics will then be applied
across cancers in collaborative research studies that include at least 2 PRCs.
Finally, the Coordinating Center will be responsible for establishing a process
in which multi-cancer research studies are proposed and recommended by the
PROSPR Steering Committee, and for data analysis in support of these studies.

The Coordinating Center will also develop and implement a
process to share PROSPR II data with other investigators outside of the PROSPR
network. The NCI is committed to having PROSPR serve as a research resource
that can be accessed by the extramural community, to expand the depth and
breadth of research that can be conducted. Consequently, there is an
expectation that PROSPR investigators make data and scientific resources
available to external investigators for research purposes. This research will
generally be conducted in collaboration with PROSPR investigators, as
successful research projects will depend on detailed knowledge of the strengths
and limitations of the data, as well as the context in which screening-related
healthcare is delivered in the participating PROSPR healthcare systems. The
Coordinating Center will develop and oversee a process by which potential
external collaborators can learn about the network and propose research
projects to be vetted by the Steering Committee.

Tasks of the PROSPR II Coordinating Center are varied, and
consequently it is expected that the study team be assembled with appropriate
expertise in such areas as:

Health services and healthcare delivery

Implementation science

Cancer epidemiology, including specifically expertise in
screening for each of the 3 target cancer types

Health disparities research

Biostatistics

Bioinformatics and health information technology

To increase the likelihood that the functions and tasks of
the Coordinating Center can be performed successfully, applicants should have
experience in coordinating multi-institutional, trans-disciplinary research. In
addition to its scientific duties, the PCC will also be responsible for the
administrative management of trans-PROSPR network activities. This includes but
is not limited to facilitating the formation of working groups, scheduling and
coordinating logistics of teleconferences and in-person meetings, and approval
and tracking of trans-PROSPR research studies.

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH scientific or program
staff will assist, guide, coordinate, or participate in project activities. See
Section VI.2 for additional information about the substantial involvement for
this FOA.

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

NCI intends to commit $1.5 million in FY 2018 to fund 1
award.

Award Budget

Applications are limited to a total of $1 million per year
in direct costs.

Award Project Period

A project period of 5 years must be proposed.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit only one application in
response to this FOA.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the Research Instructions for the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed with the following modification:

For this specific FOA, the Research Strategy section is
limited to 30 pages.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

Facilities
and Resources: Include any information about available unique
resources and/or special capabilities that may be relevant for future network
collaborative research activities.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed. Additional guidance applies.

Please identify investigators who will lead the various
tasks for the PCC, specifically administrative/management, measures development,
trans-PROSPR research procedures, and data sharing procedures. Also indicate
other specific individuals who may be considered Senior/Key Personnel.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed. Additional guidance applies.

PD/PI
Effort Commitment. Any PD/PI (whether designated as contact or not)
must commit a minimum of 1.2 person-months per year to the award. This
commitment cannot be reduced in later years of the award. Note that this is a
minimum effort level that should be increased as appropriate to meet the needs
of the work.

It is expected that the approximately 70% of direct costs
requested would be allocated to measures development and trans-PROSPR research
combined. Note that the effort devoted to measures development may predominate
in earlier years of funding, and trans-PROSPR research may predominate later.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Specific
Aims: Outline the general objectives of the proposed PROSPR
Coordinating Center and the

overall approach to achieving these goals.

Research
Strategy: The Research Strategy section should document the
applicant's experience in coordinating multi-institutional, trans-disciplinary
research, and should outline plans for carrying out the main functions of the
Coordinating Center. The Research Strategy section must consist of subsections
A-D as designated below.

Subsection
A. Administrative processes for the PCC

Explain the collective capabilities of the study team in terms of
their qualifications and experiences in coordinating large, multisite research
initiatives, and their qualifications in conducting cancer screening research
in community settings. Emphasize how the combined, interdisciplinary experience
of the team will meet the needs of the PCC activities. Do not repeat
information already provided in biosketches.

Describe the organizational and governing structure for the PCC,
lines of authority, and decision making processes.

Subsection
B. Measures Development

Propose a process for interacting with the PRCs and NCI to
develop standardized frameworks and measures to assess (1) system-level factors
that may be associated with the screening process, and (2) screening quality.
Include a discussion of:

The collective expertise and qualifications of the study team in
assessing system-level factors and cancer screening quality (do not repeat
information already provided in biosketches).

Vision and rationale for key data to be collected in assessing
system-level factors and screening quality.

A proposed process and timeline for incorporating and harmonizing
system-level factors and screening quality data captured by individual PRCs
into a broader context that cuts across cancer types.

Subsection
C. Trans-PROSPR Research

Propose a process for the development and conduct of trans-PROSPR
research studies (i.e., those involving more than one cancer type and PRC) within
the PROSPR II network. Include a discussion of:

Vision for the types of research projects that could be conducted
across 2 or 3 cancer types.

Proposed approach to the development of data sharing processes.

Proposed process and timeline for the solicitation,
prioritization, selection, and conduct (including data analysis) of the
research projects.

Subsection
D. Data Sharing Process Development

Outline a process by which the PCC will work with the PRCs
and with NCI to develop policies and procedures for qualified investigators
outside of the PROSPR II network to gain access to data for research purposes.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
NIH and Grants.gov systems check the application against many of the
application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant
and/or nonresponsive will not be reviewed.

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

Merit evaluation should reflect the likelihood that the
Coordinating Center can promote research across multiple PRCs with a high
potential for improving the cancer screening process. The review should emphasize
on the applicant's vision for assessment of the screening process (especially
development of common conceptualizations and measures of system-level factors
and screening quality), and the proposed processes for stimulating
collaborative research.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the
research network that it will coordinate? Is the scope of activities proposed
for the Center appropriate to meet those needs? Will successful completion of
the aims bring unique advantages or capabilities to the research network?

Specific to this FOA: Is
the PCC’s vision for the assessment of system-level factors and screening
quality likely to lead to research that will improve the cancer screening
process?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited
to their roles in the Center? Do they have appropriate experience and training,
and have they demonstrated experience and an ongoing record of accomplishments
in managing cancer screening process research? Do the investigators demonstrate
significant experience with coordinating collaborative clinical research? If
the Center is multi-PD/PI, do the investigators have complementary and
integrated expertise and skills; are their leadership approach, governance,
plans for conflict resolution, and organizational structure appropriate for the
Center? Does the applicant have experience overseeing selection and management
of subawards, if needed?

Specific to this FOA: Is
the range of expertise of the investigator team sufficient to facilitate the
conduct of high-impact research related to the cancer screening process? Is the
collective expertise of the team sufficiently broad and interdisciplinary? What
is the experience of the participating investigators in large-scale
collaborative research in community healthcare settings?

Innovation

Does the application propose novel organizational
concepts in coordinating the research network the Center will serve? Are the
concepts, strategies, or instrumentation novel to one type of research program
or applicable in a broad sense? Is a refinement, improvement, or new
application of organizational concepts proposed?

Specific to this FOA: Does
the applicant propose novel approaches for the assessment of system-level
factors and screening quality? Does the applicant's vision include collection
of data elements that have not or have rarely been collected before but that
have high potential for improving our understanding of how to improve the
screening process? Does the applicant propose innovative methods for gaining
insight into improving the cancer screening process?

Approach

Are the overall strategy, operational plan, and
organizational structure well-reasoned and appropriate to accomplish the goals
of the research network the Center will serve? Will the investigators promote
strategies to ensure a robust and unbiased scientific approach across the network,
as appropriate for the work proposed? Are potential problems, alternative
strategies, and benchmarks for success presented? If the network is in the
early stages of operation, does the proposed strategy adequately establish
feasibility and manage the risks associated with the activities of the network?
How appropriate are the proposed work-flow and timeline? Have the
investigators presented adequate plans to ensure consideration of relevant
biological variables, such as sex, for studies of vertebrate animals or human
subjects?

Specific to this FOA: Are
the proposed processes and timelines for developing collaborative research
between multiple PRCs and for data sharing with outside investigators likely to
result in successful collaborations and impactful research? How promising are
the approaches and timeline for harmonizing system-level factors and screening
quality data captured by individual PRCs into a broader context that cuts
across cancer types? Will the plan proposed for the analysis of data from
multiple PRCs promote the successful completion of trans-PROSPR research?

Environment

Will the institutional environment in which the
Center will operate contribute to the probability of success in facilitating
the research network it serves? Are the institutional support, equipment and
other physical resources available to the investigators adequate for the Center
proposed? Will the Center benefit from unique features of the institutional
environment, infrastructure, or personnel? Are resources available within the
scientific environment to support electronic information handling?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the scientific
goals and research strategy proposed. For additional information on review of
the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key biological and/or chemical resources,
reviewers will comment on the brief plans proposed for identifying and ensuring
the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the National Cancer Advisory Board. The following will be considered
in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These costs
may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”
This provision will apply to all NIH grants and cooperative agreements except
fellowships.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.

The
PD(s)/PI(s) will have the primary responsibility for:

Leading the development of common conceptualizations and measures
for 2 aspects of the screening process: assessing the role of systems-level
factors, and assessing quality;

Implementing a process for the development, approval, and conduct
of research that uses the above measures to evaluate the cancer screening
process across multiple cancer types (i.e., via collaborations involving 2 or 3
PRCs), and participating in the development and conduct of this research as
appropriate;

Overseeing the conduct of data analysis in support of approved
PROSPR research that involves multiple cancer types;

Developing and implementing a process to support the sharing of
PROSPR data with qualified investigators who are not part of the PRCs, PCC, or
NCI;

Abiding by the PROSPR governance document, which will be
developed during the first year of funding, and by decisions of the PROSPR
Steering Committee;

Providing information to the NCI Program Director and NCI Project
Scientists concerning progress by submitting annual progress reports in a
standard format, and by providing additional information as needed;

Hosting annual site visits to be conducted by NCI staff;

Cooperating with NCI Project Scientists in the program evaluation
process;

Committing a minimum of 1.2-person-months effort per year to the
award; and

Assuring that appropriate administrative and logistical support
is provided to coordinate trans-PROSPR research activities (including but not
limited to facilitating the formation of working groups, scheduling and
coordinating logistics of teleconferences and in-person meetings, and approval
and tracking of trans-PROSPR research projects).

Awardees will retain custody of and have primary rights to
the data and software developed under these awards, subject to Government
rights of access consistent with current DHHS, PHS, and NIH policies.

NIH
staff have substantial programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below:

One or more NCI Project Scientists will have the following
responsibilities:

Advising on the development of common conceptualizations and
metrics for assessing the role of systems-level factors that impact the
screening process, and assessing the quality of the screening process;

Participating in the development and conduct of trans-PROSPR
research as appropriate;

Collaborating with the PROSPR investigators in some shared
activities, including co-authoring papers if appropriate;

Monitoring the operations of the PRCs and the PCC, and making
recommendations on overall project directions and allocations of project funds;

Reviewing the individual progress of the PRCs and PCC, as well as
the progress of multisite PROSPR collaborations;

Assisting the PROSPR awardees as a liaison in stimulating their
broader interactions with other NCI and NIH programs to disseminate results and
outcomes from the PROSPR program and effectively leverage existing NIH/NCI
resources and infrastructures;

Evaluating the adherence of PROSPR awardees to the approved data
sharing plans and intellectual property plans; and

Conducting site visits for all PRCs and the PCC annually.

Additionally, an NCI Program staff member will serve as Program
Official, who will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the Notice of Award.

Areas
of Joint Responsibility include:

The PROSPR Steering Committee will serve as the main
governing board of the PROSPR network. The committee will consist of the
following voting members:

Three representatives from each PRC (or more if necessary, such
that there is one representative from each participating healthcare system),
who will collectively have one vote;

The PD(s)/PI(s) of the PCC who will collectively have one vote;
and

The NCI Project Scientists who will collectively have one vote.

The PROSPR Steering Committee will meet at least twice
annually in person. A chair of the Steering Committee will be selected at the
first meeting to coordinate the committee's operation, and will serve a term of
12 months.

The
PROSPR Steering Committee will have the following primary responsibilities:

Reviewing and prioritizing the trans-network research goals, and
overseeing the overall progress of trans-PROSPR research activities;

Establishing advisory committees and subcommittees, as necessary,
to ensure the progress of PROSPR's collaborative research;

Approving and prioritizing collaborative research projects that
include multiple PRCs and/or investigators external to the PROSPR network;

Participating in the development of an agenda for the biannual
PROSPR scientific meetings; and

Developing a PROSPR governance document for trans-PROSPR work,
which must be drafted and approved during the first year of funding.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of information
reported in the System for Award Management (SAM) about civil, criminal,
and administrative proceedings in connection with the award or performance of a
Federal award that reached final disposition within the most recent five-year
period. The recipient must also make semiannual disclosures regarding
such proceedings. Proceedings information will be made publicly available
in the designated integrity and performance system (currently FAPIIS). This is
a statutory requirement under section 872 of Public Law 110-417, as amended (41
U.S.C. 2313). As required by section 3010 of Public Law 111-212, all
information posted in the designated integrity and performance system on or
after April 15, 2011, except past performance reviews required for Federal procurement
contracts, will be publicly available. Full reporting requirements and
procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and
Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.